GMP Fill Finish Manufacturing

Sterile Product in Vial Filled Aseptically: Solution, Gel-Forming Polymer, or Micronized Suspension

 

Quality System and GMP Operations

  • DDE Labs consists of a Development and GMP Laboratory
  • Pharmaceutical development laboratory for developing parenteral formulations, processes, and analytical methods for drug product
  • Clean suite for aseptic manufacturing under GMP conditions of early phase clinical trial materials and toxicity test article.
  • Injectable solutions, suspensions, and gel formulations
  • GMP release and stability testing is conducted for product specific methods
  • GMP operation is monitored by on-site QA
  • Certificate of Compliance and Certificate of Analysis provided for each batch manufacture

GMP Facility for Manufacture of Clinical Materials

  • Flexible facility for phase 1 and early phase 2 clinical material
  • GLP toxicity test article
  • Hand fill or semi-automated fill in laminar flow hood
  • Vials from 1, 5, 10, 20 mL and up
  • Batch size up to 10 to 20 liters
  • Solution, suspension, viscous liquids, aqueous and non-aqueous

Staging Area for Clean Suite

  • Staging area with autoclave, depyrogenation oven, compounding laminar flow hood, pass through and pressure sensors for clean suite, and development lyophilizer

                                                

QC Laboratory

  • Release of incoming raw materials, QC for manufactured batch, and 24/7 monitored stability chambers with ICH, refrigerated, and frozen storage conditions
  • QC Lab for incoming raw material, QC release, and stability testing
  • Micro testing and other selected testing outsourced
  • Ports for vacuum / gas tubing
HPLC, FTIR, particle size analysis
Stability Chambers: 25°C/60%RH; 40°C/75%RH; 2-8°C, -20°C, and -80°C

 

 

 

 

 

 

 

 

 

 

Clean Suite from Inside

  • Laminar flow hood for compounding
  • Separate hood for final fill and finish
  • Pass through looking out to QC lab
  • Intercom for communication
  •  Ports for vacuum / gas tubing